AXSOS 661040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540708755), received between Nov 28, 2016 and Nov 28, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2016Detachment Of Device Component; Device Inoperable

  THE UPPER LIMB CONSULTANT, REPORTED THAT AN AXSOS III PROXIMAL LATERAL HUMERAL PLATE HAD FAILED/PULLED OFF FROM A PATIENT. THE PATIENT WAS REVISED. IT WAS FURTHER REPORTED THAT HE HAD TORQUE THE LOCKING SCREWS AND THAT HE DID NOT THINK THE BONE WAS OF POOR QUALITY. THE SURGEON WAS UNSURE WHETHER THE PATIENT HAD BEEN COMPLIANT.

  Patient problems: No Code Available

  MAUDE report 6130551 ↗